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About the Role

The Evidence Generation Lead manages all evidence generation programs, including Externally Sponsored Research (ESR), Phase 4 (P4) studies, Health Economics and Outcomes Research (HEOR), and Post-Marketing Surveillance (PMS). This role provides operational support for contracts, vendor management, budget oversight, progress monitoring, and cross-functional collaboration. The Lead ensures evidence generation program data is centrally maintained and accessible.

Responsibilities

Manage all evidence generation projects conducted by Japan Medical Affairs, including ESRs, P4 studies, Database research, and PMS.
Provide operational and technical support to medical affairs business owners.
Educate MA staffs on internal and external processes, compliance, regulation, and life-science research basics.
Facilitate TARC and communication with global counterparts.
Evaluate feasibility and timeline for studies.
Facilitate contact and assist with milestone design, CRO/vendor selection, and FMV determination.
Assist investigators in managing CRO/ARO.
Monitor project status, budget, and provide regular reports on progress, risks, and recommendations.
Monitor milestones and receive outcomes timely.
Track and facilitate publications.
Ensure studies are appropriately and compliantly closed following relevant SOPs.
Manage day-to-day study/research operational aspects to ensure Business Continuity across cross-functional groups.
Liaise with Japan MA TA members for successful project progress.
Liaise with internal and global support functions and external vendors to ensure processes are followed.
Support and maintain the overall study budget, including invoice and PO tracking.
Ensure transparency over budget responsibilities by updating relevant systems.
Manage and reconcile contracts, POs, invoices, and amendments.
Lead and resolve outstanding invoice/PO issues and communicate in a timely manner.
Manage all evidence generation program operations through providing operational supports such as facilitating contract, selecting and managing CRO/vender, evaluating FMV, monitoring progress and milestone, challenging new and innovative approaches, and collaborating with other business functions including legal/compliance.
Oversee processes, systems and activities related to evidence generation program from a variety of internal and external sources to ensure data is centrally maintained, managed and available for various stakeholders to access seamlessly in real-time.

Requirements

BS degree in a life science or technology discipline.
5+ years of experience in the pharmaceutical industry or Healthcare.
Good understanding of the medical affairs function in a pharma company.
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.
Project management experience, including cross-functional team and vendor management.
Experience with project budget planning, financial tracking and reporting.
Track record of successful collaborations with both internal and external partners.
Ability to effectively work with CRO/vendors/Academic Institutions.
Ability to proactively identify and anticipate risks of non-compliance in a complex environment.
Significant user experience with IT systems such as iEnvision, any Clinical Trial Management System and study documentation review systems.
Excellent English language verbal and written communication skills.

Skills

Project Management
Vendor Management
Budget Planning
Financial Tracking
Reporting
Collaboration
CRO/Vendor Management
Academic Institution Collaboration
Risk Identification
IT Systems (iEnvision, CTMS, study documentation review systems)
English Communication

Experience Level

5+ years of experience in pharmaceutical industry or Healthcare
2 years+ Experience in Medical Affairs, Medical Operations, clinical development or Real-World Evidence Generation

Education Level

BS degree in a life science or technology discipline

About the Company

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.
Alexion participates in E-Verify.

Equal Opportunity

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees.
To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com.